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https://www.readbyqxmd.com/read/28324167/efficacy-and-safety-of-golimumab-52-week-maintenance-therapy-in-japanese-patients-with-moderate-to-severely-active-ulcerative-colitis-a-phase-3-double-blind-randomized-placebo-controlled-study-pursuit-j-study
#1
Toshifumi Hibi, Yuya Imai, Asako Senoo, Kentaro Ohta, Yoshifumi Ukyo
BACKGROUND: The global phase 3 studies of golimumab [PURSUIT-SC and PURSUIT-maintenance (M)], an anti-tumor necrosis factor-α (anti-TNFα) antibody, have demonstrated clinical efficacy and safety as induction and maintenance therapies in patients with moderate to severely active ulcerative colitis (UC). This study aimed to evaluate the efficacy and safety of golimumab as maintenance therapy in the Japanese population. METHODS: In this phase 3, double-blind (DB), placebo-controlled, parallel group, randomized withdrawal study, 144 Japanese patients with moderately to severely active UC received golimumab doses of 200 mg (at week 0) and 100 mg (at week 2) subcutaneously during the 6-week open-label induction phase...
March 21, 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/28323989/preconception-low-dose-aspirin-restores-diminished-pregnancy-and-live-birth-rates-in-women-with-low-grade-inflammation-a-secondary-analysis-of-a-randomized-trial
#2
Lindsey A Sjaarda, Rose G Radin, Robert M Silver, Emily Mitchell, Sunni L Mumford, Brian Wilcox, Noya Galai, Neil J Perkins, Jean Wactawski-Wende, Joseph B Stanford, Enrique F Schisterman
Context: Inflammation is linked to causes of infertility. Low dose aspirin (LDA) may improve reproductive success in women with chronic, low-grade inflammation. Objective: To investigate the effect of preconception-initiated LDA on pregnancy rate, pregnancy loss, live birth rate, and inflammation during pregnancy. Design: Stratified secondary analysis of a multi-center, block-randomized, double-blind, placebo-controlled trial. Setting: Four U...
February 3, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323986/chronic-intranasal-insulin-does-not-affect-hepatic-lipids-but-lowers-circulating-bcaas-in-healthy-male-subjects
#3
Thomas Scherer, Peter Wolf, Sabina Smajis, Melania Gaggini, Martina Hackl, Amalia Gastaldelli, Peter Klimek, Elisa Einwallner, Rodrig Marculescu, Anton Luger, Clemens Fürnsinn, Siegfried Trattnig, Christoph Buettner, Martin Krššák, Michael Krebs
Context: Non-alcoholic fatty liver disease and elevated circulating branched-chain amino acids (BCAAs) are common characteristics of obesity and type 2 diabetes. In rodents, brain insulin signaling controls both hepatic triglyceride secretion and BCAA catabolism. Whether brain insulin signaling controls similar metabolic pathways in humans is unknown. Objective: Here we assessed if intranasal insulin, a method to preferentially deliver insulin to the central nervous system, is able to modulate hepatic lipid content and plasma BCAAs in humans...
January 16, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323948/dose-dependent-suppression-of-gonadotropins-and-ovarian-hormones-by-elagolix-in-healthy-premenopausal-women
#4
Juki Ng, Kristof Chwalisz, David C Carter, Cheri E Klein
Context: Elagolix is a nonpeptide, oral gonadotropin-releasing hormone (GnRH) antagonist being developed for sex-hormone dependent diseases in women. Objective: To evaluate the pharmacokinetics and pharmacodynamics of elagolix. Design, Setting, and Participants: Randomized, double-blind, placebo-controlled, multiple-ascending dose study in 45 healthy premenopausal women at a research unit. Interventions: Elagolix 150 mg once daily or 100, 200, 300 or 400 mg twice daily or placebo for 21 days...
February 16, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323947/effects-of-mixed-carotenoids-on-adipokines-and-abdominal-adiposity-in-children-a-pilot-study
#5
J Atilio Canas, Amanda Lochrie, Amy Galena McGowan, Jobayer Hossain, Christopher Schettino, P Babu Balagopal
Context: Carotenoids have been implicated in the regulation of adipocyte metabolism. Objective: To compare the effects of mixed-carotenoid supplementation (MCS) vs. placebo on adipokines and the accrual of abdominal adiposity in children with obesity. Design and Setting: Randomized (1:1) double-blind, placebo-controlled intervention trial to evaluate the effects of MCS over 6 months in a subspecialty clinic. Participants: Twenty (6 male and 14 female) children with simple obesity (BMI > 90%); age: 10...
March 13, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323916/acute-hypercortisolemia-exerts-depot-specific-effects-on-abdominal-and-femoral-adipose-tissue-function
#6
Konstantinos N Manolopoulos, Michael W O'Reilly, Iwona J Bujalska, Jeremy W Tomlinson, Wiebke Arlt
Context: Glucocorticoids have pleiotropic metabolic functions and acute glucocorticoid excess affects fatty acid metabolism, increasing systemic lipolysis. Whether glucocorticoids exert adipose tissue depot-specific effects remains unclear. Objective: In vivo assessment of femoral and abdominal adipose tissue responses to acute glucocorticoid administration. Design and outcome measures: Nine healthy male volunteers studied on two occasions, following a hydrocortisone infusion (0...
February 16, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323838/bupropion-for-the-treatment-of-apathy-in-huntington-s-disease-a-multicenter-randomised-double-blind-placebo-controlled-prospective-crossover-trial
#7
Harald Gelderblom, Torsten Wüstenberg, Tim McLean, Lisanne Mütze, Wilhelm Fischer, Carsten Saft, Rainer Hoffmann, Sigurd Süssmuth, Peter Schlattmann, Erik van Duijn, Bernhard Landwehrmeyer, Josef Priller
OBJECTIVE: To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington's disease (HD). METHODS: In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy-Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant...
2017: PloS One
https://www.readbyqxmd.com/read/28323806/improving-pain-management-and-long-term-outcomes-following-high-energy-orthopaedic-trauma-pain-study
#8
Renan C Castillo, Srinivasa N Raja, Katherine P Frey, Heather A Vallier, Paul Tornetta, Todd Jaeblon, Brandon J Goff, Allan Gottschalk, Daniel O Scharfstein, Robert V OʼToole
Poor pain control after orthopaedic trauma is a predictor of physical disability and numerous negative long-term outcomes. Despite increased awareness of the negative consequences of poorly controlled pain, analgesic therapy among hospitalized patients after orthopaedic trauma remains inconsistent and often inadequate. The Pain study is a 3 armed, prospective, double-blind, multicenter randomized trial designed to evaluate the effect of standard pain management versus standard pain management plus perioperative nonsteroidal anti-inflammatory drugs or pregabalin in patients of ages 18-85 with extremity fractures...
April 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28323798/supplemental-perioperative-oxygen-to-reduce-surgical-site-infection-after-high-energy-fracture-surgery-oxygen-study
#9
Robert V OʼToole, Manjari Joshi, Anthony R Carlini, Robert A Sikorski, Armagan Dagal, Clinton K Murray, Michael J Weaver, Ebrahim Paryavi, Alec C Stall, Daniel O Scharfstein, Julie Agel, Mary Zadnik, Michael J Bosse, Renan C Castillo
Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation...
April 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28320187/repeated-transcranial-direct-current-stimulation-in-prolonged-disorders-of-consciousness-a-double-blind-cross-over-study
#10
Anna Estraneo, Angelo Pascarella, Pasquale Moretta, Orsola Masotta, Salvatore Fiorenza, Grazia Chirico, Emanuela Crispino, Vincenzo Loreto, Luigi Trojano
OBJECTIVE: To evaluate effects of 5 sessions of transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex in patients with prolonged disorders of consciousness (DOC). METHODS: Seven patients in vegetative state (VS) and 6 in minimally conscious state (MCS), at ≥3months after brain injury, were randomized into two groups: group 1 received one week of active tDCS and 1week of sham stimulation, separated by 1 resting week; group 2 received active and sham stimulation in reverse order...
April 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28319997/intradiscal-glucocorticoid-injection-for-patients-with-chronic-low-back-pain-associated-with-active-discopathy-a-randomized-trial
#11
Christelle Nguyen, Isabelle Boutron, Gabriel Baron, Katherine Sanchez, Clémence Palazzo, Raphaël Benchimol, Guillaume Paris, Étienne James-Belin, Marie-Martine Lefèvre-Colau, Johann Beaudreuil, Jean-Denis Laredo, Anne Béra-Louville, Anne Cotten, Jean-Luc Drapé, Antoine Feydy, Philippe Ravaud, François Rannou, Serge Poiraudeau
Background: Active discopathy is associated with a specific phenotype of chronic low back pain (LBP). Local inflammation has a role in active discopathy-associated symptoms. Objective: To assess the efficacy of a single glucocorticoid intradiscal injection (GC IDI) in patients with chronic LBP with active discopathy. Design: Prospective, parallel-group, double-blind, randomized, controlled study. (ClinicalTrials.gov: NCT00804531). Setting: 3 tertiary care centers in France...
March 21, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28319947/effects-of-capsaicin-on-older-patients-with-oropharyngeal-dysphagia-a-double-blind-placebo-controlled-crossover-study
#12
Rui Nakato, Noriaki Manabe, Sayako Shimizu, Kozo Hanayama, Akiko Shiotani, Jiro Hata, Ken Haruma
BACKGROUND/AIMS: The standard of care for older patients with oropharyngeal dysphagia (OD) is poor. Stimulation of transient receptor potential vanilloid 1 might become a pharmacological strategy for these patients. This study aimed to compare the therapeutic effect of film food containing 0.75 µg of capsaicin in these patients. METHODS: In a crossover, randomized trial, 49 patients with OD were provided capsaicin or identical placebo at least 7 days apart. Patients' reported symptoms during repeated swallowing, the volume, pH and substance P (SP) concentrations in saliva, and cervical esophageal wall motion evaluated by ultrasonographic tissue Doppler imaging were obtained before and after capsaicin or placebo administration...
March 21, 2017: Digestion
https://www.readbyqxmd.com/read/28319848/treatment-of-premenstrual-dysphoric-disorder-with-the-gabaa-receptor-modulating-steroid-antagonist-sepranolone-uc1010-a-randomized-controlled-trial
#13
Marie Bixo, Karin Ekberg, Inger Sundström Poromaa, Angelica Lindén Hirschberg, Aino Fianu Jonasson, Lotta Andréen, Erika Timby, Marianne Wulff, Agneta Ehrenborg, Torbjörn Bäckström
CONTEXT: Allopregnanolone is a metabolite from progesterone and a positive modulator of the GABAA receptor. This endogenous steroid may induce negative mood in sensitive women when present in serum levels comparable to the premenstrual phase. Its endogenous isomer, isoallopregnanolone, has been shown to antagonize allopregnanolone effects in experimental animal and human models. OBJECTIVE: The objective was to test whether inhibition of allopregnanolone by treatment with the GABAA modulating steroid antagonist (GAMSA) Sepranolone (UC1010) during the premenstrual phase could reduce symptoms of the premenstrual dysphoric disorder (PMDD)...
March 1, 2017: Psychoneuroendocrinology
https://www.readbyqxmd.com/read/28319467/effects-of-iv-acetaminophen-on-core-body-temperature-and-hemodynamic-responses-in-febrile-critically-ill-adults-a-randomized-controlled-trial
#14
Hildy M Schell-Chaple, Kathleen D Liu, Michael A Matthay, Daniel I Sessler, Kathleen A Puntillo
OBJECTIVE: To determine the effects of IV acetaminophen on core body temperature, blood pressure, and heart rate in febrile critically ill patients. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Three adult ICUs at a large, urban, academic medical center. PATIENTS: Forty critically ill adults with fever (core temperature, ≥ 38.3°C). INTERVENTION: An infusion of acetaminophen 1 g or saline placebo over 15 minutes...
March 17, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28319422/phototherapy-for-improvement-of-performance-and-exercise-recovery-comparison-of-3-commercially-available-devices
#15
Thiago De Marchi, Vinicius Mazzochi Schmitt, Carla Danúbia da Silva Fabro, Larissa Lopes da Silva, Juliane Sene, Olga Tairova, Mirian Salvador
CONTEXT:   Recent studies suggest the prophylactic use of low-powered laser/light has ergogenic effects on athletic performance and postactivity recovery. Manufacturers of high-powered lasers/light devices claim that these can produce the same clinical benefits with increased power and decreased irradiation time; however, research with high-powered lasers is lacking. OBJECTIVE:   To evaluate the magnitude of observed phototherapeutic effects with 3 commercially available devices...
March 20, 2017: Journal of Athletic Training
https://www.readbyqxmd.com/read/28319243/association-of-antioxidant-supplement-use-and-dementia-in-the-prevention-of-alzheimer-s-disease-by-vitamin-e-and-selenium-trial-preadvise
#16
Richard J Kryscio, Erin L Abner, Allison Caban-Holt, Mark Lovell, Phyllis Goodman, Amy K Darke, Monica Yee, John Crowley, Frederick A Schmitt
Importance: Oxidative stress is an established dementia pathway, but it is unknown if the use of antioxidant supplements can prevent dementia. Objective: To determine if antioxidant supplements (vitamin E or selenium) used alone or in combination can prevent dementia in asymptomatic older men. Design, Setting, and Participants: The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADViSE) trial began as a double-blind randomized clinical trial in May 2002, which transformed into a cohort study from September 2009 to May 2015...
March 20, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28318988/analgesic-effects-of-morphine-and-butorphanol-in-broiler-chickens
#17
Preet M Singh, Craig B Johnson, Brett Gartrell, Sheryl Mitchinson, Antony Jacob, Paul Chambers
OBJECTIVE: To evaluate analgesic efficacies of morphine and butorphanol in lame broiler chickens. STUDY DESIGN: Double blind, randomized, controlled experimental study. ANIMALS: In study 1, 36 lame and 36 sound chickens. In study 2, 48 lame and 48 sound chickens. METHODS: Sound and lame chickens were gait scored and randomly assigned into four groups: sound-drug, sound-placebo, lame-drug, and lame-placebo in study 1...
January 11, 2017: Veterinary Anaesthesia and Analgesia
https://www.readbyqxmd.com/read/28318926/effectiveness-of-tranexamic-acid-for-reducing-intraoperative-bleeding-in-palatoplasties-a-randomized-clinical-trial
#18
Guilherme C Arantes, Rui Manoel R Pereira, Daniela B de Melo, Nivaldo Alonso, Maria do Carmo M B Duarte
BACKGROUND: Few data are available regarding blood loss during cleft palate surgery. This study assessed the effect of using tranexamic acid in the reduction of intraoperative bleeding. METHODS: A double-blind, randomized clinical trial compared intraoperative bleeding and the incidence of oronasal fistulas after palatoplasties in a control group that was given placebo and an intervention group that was given 10 mg/kg tranexamic acid followed by a continuous infusion of 1 mg/kg/h of the same until the end of surgery...
December 30, 2016: Journal of Cranio-maxillo-facial Surgery
https://www.readbyqxmd.com/read/28318850/safety-and-efficacy-of-hyperosmolar-irrigation-solution-in-shoulder-arthroscopy
#19
Nicholas M Capito, James L Cook, Bernardo Yahuaca, Marie D Capito, Seth L Sherman, Matthew J Smith
BACKGROUND: A hyperosmolar irrigation solution has been reported to be safe and have potential benefits for use during shoulder arthroscopy in an animal model study. In this study, the clinical effects of a hyperosmolar solution were compared with a standard isotonic solution when used for shoulder arthroscopy. METHODS: A prospective, double-blind, randomized controlled trial was performed to compare isotonic (273 mOsm/L) and hyperosmolar (593 mOsm/L) irrigation solutions used for arthroscopic rotator cuff repair...
March 15, 2017: Journal of Shoulder and Elbow Surgery
https://www.readbyqxmd.com/read/28318835/improvement-in-mismatch-negativity-generation-during-d-serine-treatment-in-schizophrenia-correlation-with-symptoms
#20
Joshua T Kantrowitz, Michael L Epstein, Migyung Lee, Nayla Lehrfeld, Karen A Nolan, Constance Shope, Eva Petkova, Gail Silipo, Daniel C Javitt
BACKGROUND: Deficits in N-methyl-d-aspartate-type (NMDAR) function contribute to symptoms and cognitive dysfunction in schizophrenia. The efficacy of NMDAR agonists in the treatment of persistent symptoms of schizophrenia has been variable, potentially reflecting limitations in functional target engagement. We recently demonstrated significant improvement in auditory mismatch negativity (MMN) with once-weekly treatment with d-serine, a naturally occurring NMDAR glycine-site agonist. This study investigates effects of continuous (daily) NMDAR agonists in schizophrenia/schizoaffective disorder...
March 17, 2017: Schizophrenia Research
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